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Clinical Trial · NCT04168528
Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT
Overview
Phase I study to evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2 Phase IIa study to evaluate tumour uptake of 68Ga-NOTA-anti-MMR-VHH2 in patients with breast cancer or melanoma. To correlate uptake of 68Ga-NOTA-anti-MMR-VHH2 in cancer lesions to immunohistological MMR staining after resection or biopsy of the same lesion.
Sponsor
Unknown Organization
Phase
Phase 1/2
Contacts
Tony LAHOUTTE, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT04168528Drug / Compound
NOTA-Anti-MMR-VHH2
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- Mannose Receptor (CD206/MRC1)
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA
NOTA-Anti-MMR-VHH2
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- Mannose Receptor (CD206/MRC1)
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA
Eligibility
Inclusion
- Patients who have given informed consent
- Patients with local, locally advanced or metastatic disease of a malignant solid tumor. In order to minimize partial volume effect the diameter of at least 1 tumor lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
- Patients will only be included in the study if they meet all of the following criteria:
- Patients at least 18 years old
Exclusion
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- Pregnant patients
- Patients with abnormal liver (Bilirubin ≥1.5 x ULN, ALT (SGPT) ≥3 x ULN) or kidney function (Serum creatinine clearance ≤50 ml/min as calculated with Cockcroft-Gault formula)
- Breast feeding patients
- Patients will not be included in the study if one of the following criteria applies:
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